MEDWATCH for MANDATORY reporting

1 Dateof Birth:A. PATIENT INFORMATIONFDA Use OnlyForm Approved: OMB No. 0910-0291, Expires: 6/30/2015 See OMB statement on FDA 3500A (2/13)E. INITIAL Attributed to Adverse Event(Check all that apply)Adverse Eventand/orProduct Problem( , defects/malfunctions) of Event(mm/dd/yyyy) of This Report(mm/dd/yyyy) Event or Tests/Laboratory Data, Including Relevant History, Including Preexisting Medical Conditions( , allergies,race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)Expiration Date(mm/dd/yyyy)For use by user-facilities,importers, distributors and manufacturersfor MANDATORY reportingB. ADVERSE EVENT OR PRODUCT Device of Implanted, Give Date(mm/dd/yyyy) Available for Evaluation?(Do not send to FDA) Explanted, Give Date(mm/dd/yyyy) Name, City and # and Medical Products and Therapy Dates(Exclude treatment of event)D.

2 SUSPECT MEDICAL DEVICENoReturned to Manufacturer Professional?Phone #Email Reporter Also SentReport to Department of Health and Human ServicesFood and Drug AdministrationIn at Timeof IdentifierMaleUnique Identifier (UDI) #Serial # Yes to Item No. 8, Enter Name and Address of ReprocessorCatalog #Lot #Other:Yesor(mm/dd/yyyy)PLEASE TYPE OR USE BLACK INKMfr Report #Submission of a report does not constitute an admission that medicalpersonnel, user facility, importer, distributor, manufacturer or productcaused or contributed to the ProfessionalLay User/PatientUF/Importer Report # this a Single-use Device that was Reprocessed and Reused on a Patient?C. SUSPECT PRODUCT(S) (Give labeled strength & mfr/labeler)# , Frequency & Route Used#2#1#2#1# Dates(If unknown, give duration)from/to (or best estimate) for Use(Indication)#1# ## # or Unique Medical Products and Therapy Dates(Exclude treatment of event)# Date#1#2 YesYesNo#1 Doesn' Reappeared AfterReintroduction?

3 YesNoNo#1#2 Doesn'tApplyDoesn' Abated After UseStopped or Dose Reduced?YesNo#2 Doesn'tApplyHospitalization - initial or prolongedRequired Intervention to Prevent Permanent Impairment/Damage (Devices)Life-threatening(mm/dd/yyyy)Con genital Anomaly/Birth DefectDeath:Disability or Permanent DamageOther Serious (Important Medical Events) MEDWATCH Page 1 of 2b. Procode(Continue on page 3) (Continue on page 3) (Continue on page 3) (Continue on page 3) (Continue on page 3) Manufacturer Dataand / orF. FOR USE BY USER FACILITY/IMPORTER(Devices only )FDA USE ONLYH. DEVICE MANUFACTURERS ONLYG. ALL Facility or Importer Report NumberUser User Facility orImporter BecameAware of Event(mm/dd/yyyy)(Specify) of of Problem Codes(Refer to coding manual) Sent to FDA? of This Report(mm/dd/yyyy) Where Event Sent to Manufacturer?OutpatientDiagnostic FacilityOutpatient TreatmentFacilityConclusionsNursing HomeFollow-up #Yes(mm/dd/yyyy)YesInitialOther:Health Professional(A)NDA #No(mm/dd/yyyy)YesEvaluation Summary Office (and Manufacturing Site for Devices) Event Term(s) Source(Check all that apply) IND, Give Protocol # of Report(Check all that apply) Received byManufacturer(mm/dd/yyyy) Report NumberYesForeignStudy5-dayModification/A djustmentConsumer7-dayOTC Product10-dayUser FacilityDistributorOther:PeriodicPMA/510 (k) # of Reportable Follow-up, What Type?

4 AmbulatorySurgical Evaluated by Manufacturer? Manufacture Date(mm/yyyy) for Single Use?No(Attach page to explain why not)orprovide Problem and Evaluation Codes (Refer to coding manual) Remedial Action Initiated, Check TypeIf action reported to FDA under21 USC 360i(f), list correction/removal reporting of DeviceYesDeathHospitalNotificationInspec tionPatient MonitoringResultsYesNot Returned to ManufacturerSerious InjuryMalfunctionRelabelingCorrectionAdd itional InformationResponse to FDA RequestDevice EvaluationInitial Use of DeviceReuseUnknownOther:RecallRepairRepl ace15-dayYesPre-1938 BLA #IND #FORM FDA 3500A (2/13) (continued)MEDWATCHI nitialFollow-up # ____DeviceCodePatientCodePage 2 of Email AddressAddressDepartment of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff section applies only to requirements of the Paperwork Reduction Act of 1995.

5 The public reporting burden for this collection of information has been estimated to average 66 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:Please DO NOT RETURN this form to the above PRA Staff email Statement: "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."(CONTINUATION PAGE)For use by user-facilities, importers, distributors, and manufacturers for MANDATORY reportingConcomitant Medical Products and Therapy Dates (Exclude treatment of event) (For continuation of and/or ; please distinguish)Other Describe Event or Problem (continued) Relevant Tests/Laboratory Data, Including Dates (continued) Other Relevant History, Including Preexisting Medical Conditions ( , allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)

6 (continued)Page 3 of FORM FDA 3500A (2/13) (continued)MEDWATCHD elete PageBack to Item to Item to Item to Item to Item